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Gadoterate Meglumine 376.9 mg/mL Injection — NDC 65219-0080-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gadoterate Meglumine 376.9 mg/mL Injection — NDC 65219-080-05 (Billing 65219-0080-05)

by Fresenius Kabi USA, LLC · 10 CARTON in 1 BOX / 1 VIAL in 1 CARTON / 5 mL in 1 VIAL

This is a package of Gadoterate Meglumine 376.9 mg/mL Injection from Fresenius Kabi USA, LLC, marketed since Jun 2022 and currently FDA-listed. It is this product's only package size.

NDC 65219-0080-05
🏷️ FDA NDC (as labeled) 65219-080-05 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 65219-080-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65219 labeler · 080 product · 05 package
Package marketed since
Jun 20, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0365219086017, 0365219084013, 0365219080015, 0365219082019
FDA record last changed
Jul 24, 2026
⚠️
Active FDA shortage. Gadoterate Meglumine Injection is currently reported in shortage by the FDA. Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65219-080-05
Product NDC 65219-080
11-digit billing NDC 65219008005
NCPDP billing unit ML — per mL (volume)
UNII L0ND3981AG
UPC 0365219086017, 0365219084013, 0365219080015, 0365219082019
Application # ANDA215304
SPL Set ID e0655aac-9508-4141-94f5-fcca6af1c41d
Established class (EPC) Gadolinium-based Contrast Agent
Mechanism of action Magnetic Resonance Contrast Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-20
Route INTRAVENOUS
Dosage form INJECTION
Substance GADOTERATE MEGLUMINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 079378
GCN 39783
HICL code 011774
Ingredient (HICL) Gadoterate Meglumine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H1
Therapeutic class — intermediate (HIC2) Drugs Affecting Principally The Brain
HIC3 code H1U
Therapeutic class — specific (HIC3) Cerebral Spinal Radiopaque Diagnostics
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name GADOTERATE 2.5 MMOL/5 ML VIAL
FDB brand name Gadoterate Meglumine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079378
  • GCN: 39783
  • HICL (First Databank): 011774
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 65219-080-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65219-0080-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name GADOTERATE 2.5 MMOL/5 ML VIAL Ingredient Gadoterate Meglumine
📗 Our plain-language guide HelloPharmacist
  • It is a contrast agent that makes your MRI pictures clearer. It helps your doctor see problems in the brain and spine, like areas where the blood-brain barrier is disrupted or bloo...
  • A healthcare professional gives it through an IV in your vein, usually as one quick injection. Your dose is based on your weight, and the scan can start right away. You do not need...
  • Most people have none. The most common ones are nausea, headache, pain or coldness where the needle went in, and rash. They are usually mild and short-lived.
  • Tell us before your scan. In people with severe kidney disease or acute kidney injury, contrast agents like this raise the risk of NSF, a serious condition that hardens skin, muscl...
📖 Read our full Gadoterate Meglumine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · A9575 $0.090 / A9575 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)65219-080-05
11-digit billing NDC65219-0080-05
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeA9575
Descriptor0.1 ML
Billing units / pkg500 units
How the units are derivedThis package is 5; the HCPCS unit is 0.1 ML, so one package = 500 billing units.
Medicare Part B spend (2026 (Q1))$1,452,352 · 91,951 claims · $15.79 per claim (all NDCs under A9575)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65219-0080-05 You're viewing this Main listing 10 CARTON in 1 BOX / 1 VIAL in 1 CARTON / 5 mL in 1 VIAL 2022-06-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gadoterate Meglumine 376.9 mg/mL 65219-0086-20 Fresenius 1 vial — — FDA listed —
Gadoterate Meglumine 376.9 mg/mL 65219-0088-50 Fresenius 1 vial — — Discontinued —
Dotarem 376.9 mg/mL 67684-2001-04 Guerbet 6 vials — AP FDA listed —
Clariscan 376.9 mg/mL 00407-2943-01 GE 10 vials — AP FDA listed —
Gadoterate Meglumine 376.9 mg/mL 65219-0082-10 Fresenius 1 vial — — FDA listed —
Dotarem 376.9 mg/mL 67684-2000-00 Guerbet 10 vials — AP FDA listed —
Dotarem 376.9 mg/mL 67684-3001-01 Guerbet 10 syringes — AP FDA listed —
Gadoterate Meglumine 376.9 mg/mLthis 65219-0080-05 Fresenius 1 vial — — FDA listed —
Gadoterate Meglumine 376.9 mg/mL 65219-0084-15 Fresenius 1 vial — — FDA listed —
gadoterate meglumine 376.9 mg/mL 70436-0123-31 Slate 10 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderJIANGSU HENGRUI PHARMACEUTICALS CO LTD
FDA applicationANDA215304 (ANDA)
Labeler code65219
First marketedJun 2022
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 65219

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadoterate Meglumine Injection is not approved for intrathecal use [see Warnings and Precautions ( 5.1 )] . Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs.

Avoid use of Gadoterate Meglumine Injection in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. • The risk for NSF appears highest among patients with: - Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or - Acute kidney injury. • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age> 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.1 ). • For patients at highest risk for NSF, do not exceed the recommended Gadoterate Meglumine Injection dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions ( 5.2 )] .

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning • Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadoterate Meglumine Injection is not approved for intrathecal use. ( 5.1 ) • GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs.

Avoid use of Gadoterate Meglumine Injection in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: o Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or o Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function.

For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.2 ).

🎯 Indications and Usage 100 words ▾

1 INDICATIONS AND USAGE Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated: for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Adult and pediatric patients: The recommended dose of Gadoterate Meglumine Injection is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection at a flow rate of approximately 2 mL/second for adults and 1 to 2 mL/second for pediatric patients (including term neonates). The dose is delivered by manual or power injection.

2.1Dosing Guidelines For adult and pediatric patients (including term neonates), the recommended dose of Gadoterate Meglumine Injection is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1 to 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes. Table 1: Volumes of Gadoterate Meglumine Injection by Body Weight Body Weight Volume Pounds (lb) Kilograms (kg) Milliliters (mL) 5.5 2.5 0.5 11 5 1 22 10 2 44 20 4 66 30 6 88 40 8 110 50 10 132 60 12 154 70 14 176 80 16 198 90 18 220 100 20 242 110 22 264 120 24 286 130 26 308 140 28 330 150 30 To ensure complete injection of Gadoterate Meglumine Injection the injection may be followed by normal saline flush.

Contrast MRI can begin immediately following injection of Gadoterate Meglumine Injection.

2.2Drug Handling • Visually inspect Gadoterate Meglumine Injection for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. Gadoterate Meglumine Injection should be a clear, colorless to yellow solution. • Do not mix with other drugs or parenteral nutrition. • Discard any unused portions of the drug.

Directions for Use of the Gadoterate Meglumine Injection Glass vial: Aseptically draw up the contrast medium into a disposable syringe and use immediately.

💊 Dosage Forms and Strengths 64 words ▾

3 DOSAGE FORMS AND STRENGTHS Gadoterate Meglumine Injection, USP 0.5 mmol per mL is a sterile, clear, colorless to yellow, aqueous solution for intravenous injection containing 376.9 mg per mL gadoterate meglumine and is available in single dose vials. Gadoterate Meglumine Injection 0.5 mmol per mL contains 376.9 mg per mL of gadoterate meglumine and is available in single dose vials. ( 3 )

⛔ Contraindications 31 words ▾

4 CONTRAINDICATIONS History of clinically important hypersensitivity reactions to Gadoterate Meglumine Injection [see Warnings and Precautions ( 5.3 )] . Clinically important hypersensitivity reactions to Gadoterate Meglumine Injection. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred. Monitor patients closely for need of emergency cardiorespiratory support. ( 5.3 ) • Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.4 )

5.1Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of Gadoterate Meglumine Injection have not been established with intrathecal use. Gadoterate Meglumine Injection is not approved for intrathecal use [see Dosage and Administration ( 2.1 )] .

5.2Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Gadoterate Meglumine Injection among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ) as well as patients with acute kidney injury.

The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 to 59 mL/min/1.73 m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60 to 89 mL/min/1.73 m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following Gadoterate Meglumine Injection administration to Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).

Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury.

For patients at risk for chronically reduced renal function (e.g., age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing. The factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient.

For patients at highest risk for NSF, do not exceed the recommended Gadoterate Meglumine Injection dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination. The usefulness of hemodialysis in the prevention of NSF is unknown [see Dosage and Administration ( 2 ) and Clinical Pharmacology ( 12 )] .

5.3Hypersensitivity Reactions Anaphylactic and anaphylactoid reactions have been reported with gadoterate meglumine, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of gadoterate meglumine administration and resolved with prompt emergency treatment [see Adverse Reactions ( 6 )] . • Before Gadoterate Meglumine Injection administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders.

These patients may have an increased risk for a hypersensitivity reaction to Gadoterate Meglumine Injection. • Administer Gadoterate Meglumine Injection only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrogenic systemic fibrosis [see Warnings and Precautions ( 5.2 )] . Hypersensitivity reactions [see Warnings and Precautions ( 5.3 )] . Gadolinium Retention [see Warnings and Precautions ( 5.4 )] The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and rash.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect gadoterate meglumine exposure in 2,867 patients, representing 2,682 adults and 185 pediatric patients. Overall, 55% of the patients were men.

In clinical trials where ethnicity was recorded, the ethnic distribution was 81% Caucasian, 11% Asian, 4% Black, and 4% others. The average age was 53 years (range from < 1 week to 97 years). Overall, 4% of patients reported at least one adverse reaction, primarily occurring immediately or within 24 hours following gadoterate meglumine administration.

Most adverse reactions were mild or moderate in severity and transient in nature. Table 2 lists adverse reactions that occurred in ≥ 0.2% patients who received gadoterate meglumine. Table 2: Adverse Reactions in Clinical Trials Reaction Rate (%) n=2,867 Nausea 0.6% Headache 0.4% Injection Site Pain 0.4% Injection Site Coldness 0.2% Rash 0.2% Adverse reactions that occurred with a frequency < 0.2% in patients who received gadoterate meglumine include: feeling cold, feeling hot, burning sensation, somnolence, pain, dizziness, dysgeusia, blood creatinine increased, hypotension, hypertension, asthenia, fatigue, injection site reactions (inflammation, extravasation, pruritus, swelling, warmth), paresthesia, pruritus, laryngeal discomfort, pain in extremity, vomiting, anxiety and palpitations.

Adverse Reactions in Pediatric Patients During clinical trials, 185 pediatric patients (52 aged < 24 months, 33 aged 2 to 5 years, 57 aged 6 to 11 years and 43 aged 12 to 17 years) received gadoterate meglumine. Overall, 7 pediatric patients (3.8%) reported at least one adverse reaction following gadoterate meglumine administration. The most frequently reported adverse reaction was headache (1.1%).

Most adverse events were mild in intensity and transient in nature.

6.2Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of gadoterate meglumine or other GBCAs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Table 3: Adverse Reactions in the Postmarketing Experience System Organ Class Adverse Reaction Cardiac Disorders bradycardia, tachycardia, arrhythmia Immune System Disorders hypersensitivity /anaphylactoid reactions including cardiac arrest, respiratory arrest, cyanosis, pharyngeal edema, laryngospasm, bronchospasm, angioedema, conjunctivitis, ocular hyperemia, eyelid edema, lacrimation increased, hyperhidrosis, urticaria Nervous System Disorders coma, convulsion, syncope, presyncope, parosmia, tremor Musculoskeletal and Connective Tissue Disorders muscle contracture, muscle weakness Gastrointestinal Disorders diarrhea, salivary hypersecretion, acute pancreatitis with onset within 48 hours after GBCA administration General Disorders and Administration Site Conditions malaise, fever Adverse reactions with variable onset and duration have been reported after GBCA administration.

These include fatigue, asthenia, pain syndr… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 28 words ▾

7 DRUG INTERACTIONS Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with gadoterate meglumine have not been conducted.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1 )

8.1Pregnancy Risk Summary GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data ) . In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses up to 16 and 10 times, respectively, the recommended human dose (see Data) .

Because of the potential risks of gadolinium to the fetus, use Gadoterate Meglumine Injection only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Data Human Data Contrast enhancement is visualized in the placenta and fetal tissues after maternal GBCA administration. Cohort studies and case reports on exposure to GBCAs during pregnancy have not reported a clear association between GBCAs and adverse effects in the exposed neonates.

However, a retrospective cohort study, comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI. Limitations of this study include a lack of comparison with non-contrast MRI and lack of information about the material indication for MRI. Overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs in pregnancy.

Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. Reproductive Toxicology Gadoterate meglumine was administered in intravenous doses of 0, 2, 4 and 10 mmol/kg/day [3, 7 and 16 times the recommended human dose (RHD) based on body surface area (BSA)] to female rats for 14 days before mating, throughout the mating period and until gestation day (GD) 17.

Pregnant rabbits were administered gadoterate meglumine in intravenous doses of 0, 1, 3 and 7 mmol/kg/day ( 3, 10 and 23 times the RHD based on BSA) from GD6 to GD19. No effects on embryo-fetal development were observed at doses up to 10 mmol/kg/day in rats and 3 mmol/kg/day in rabbits. Maternal toxicity was observed in rats at 10 mmol/kg/day and in rabbits at 7 mmol/kg/day.

This maternal toxicity was characterized in rats by a slightly lower litter size and gravid uterus weight compared to the control group, and in rabbits by a reduction in body weight and food consumption.

8.2Lactation Risk Summary There are no data on the presence of gadoterate in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk. Additionally, there is limited GBCA gastrointestinal absorption in the breast-fed infant.

Gadoterate is present in goat milk (see Data ) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Gadoterate Meglumine Injection and any potential adverse effects on the breastfed infant from Gadoterate Meglumine… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data ) . In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses up to 16 and 10 times, respectively, the recommended human dose (see Data) .

Because of the potential risks of gadolinium to the fetus, use Gadoterate Meglumine Injection only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Data Human Data Contrast enhancement is visualized in the placenta and fetal tissues after maternal GBCA administration. Cohort studies and case reports on exposure to GBCAs during pregnancy have not reported a clear association between GBCAs and adverse effects in the exposed neonates.

However, a retrospective cohort study, comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI. Limitations of this study include a lack of comparison with non-contrast MRI and lack of information about the material indication for MRI. Overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs in pregnancy.

Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. Reproductive Toxicology Gadoterate meglumine was administered in intravenous doses of 0, 2, 4 and 10 mmol/kg/day [3, 7 and 16 times the recommended human dose (RHD) based on body surface area (BSA)] to female rats for 14 days before mating, throughout the mating period and until gestation day (GD) 17.

Pregnant rabbits were administered gadoterate meglumine in intravenous doses of 0, 1, 3 and 7 mmol/kg/day ( 3, 10 and 23 times the RHD based on BSA) from GD6 to GD19. No effects on embryo-fetal development were observed at doses up to 10 mmol/kg/day in rats and 3 mmol/kg/day in rabbits. Maternal toxicity was observed in rats at 10 mmol/kg/day and in rabbits at 7 mmol/kg/day.

This maternal toxicity was characterized in rats by a slightly lower litter size and gravid uterus weight compared to the control group, and in rabbits by a reduction in body weight and food consumption.

🧒 Pediatric Use 217 words ▾

8.4Pediatric Use The safety and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg have been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see Clinical Studies ( 14 )] . Adverse reactions in pediatric patients were similar to those reported in adults [see Adverse Reactions ( 6.1 )] .

No dosage adjustment according to age is necessary in pediatric patients [see Dosage and Administration ( 2.1 ), Pharmacokinetics ( 12.3 )] . The safety of gadoterate meglumine has not been established in preterm neonates. No cases of NSF associated with gadoterate meglumine or any other GBCA have been identified in pediatric patients age 6 years and younger [see Warnings and Precautions ( 5.2 )] .

Normal estimated GFR (eGFR) is approximately 30 mL/minute/1.73m 2 at birth and increases to adult values by 2 years of age. Juvenile Animal Data Single and repeat-dose toxicity studies in neonatal and juvenile rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants.

🧓 Geriatric Use 77 words ▾

8.5Geriatric Use In clinical studies of gadoterate meglumine, 900 patients were 65 years of age and over, and 304 patients were 75 years of age and over. No overall differences in safety or efficacy were observed between these subjects and younger subjects. In general, use of Gadoterate Meglumine Injection in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy.

No age-related dosage adjustment is necessary.

🆘 Overdosage 57 words ▾

10 OVERDOSAGE Gadoterate Meglumine Injection administered to healthy volunteers and to adult patients at cumulative doses up to 0.3 mmol/kg was tolerated in a manner similar to lower doses. Adverse reactions to overdosage with gadoterate meglumine have not been reported. Gadoterate meglumine can be removed from the body by hemodialysis [See Clinical Pharmacology ( 12.3 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: 1. differences in proton density 2. differences of the spin-lattice or longitudinal relaxation times (T1) 3. differences in the spin-spin or transverse relaxation time (T2) When placed in a magnetic field, gadoterate shortens the T1 and T2 relaxation times in target tissues.

At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.

12.2Pharmacodynamics Gadoterate affects proton relaxation times and consequently the MR signal, and the contrast obtained is characterized by the relaxivity of the gadoterate molecule. The relaxivity values for gadoterate are similar across the spectrum of magnetic field strengths used in clinical MRI (0.2 to

1.5T). Disruption of the blood-brain barrier or abnormal vascularity allows distribution of gadoterate in lesions such as neoplasms, abscesses, and infarcts.

12.3Pharmacokinetics The pharmacokinetics of total gadolinium assessed up to 48 hours following an intravenously administered 0.1 mmol/kg dose of gadoterate meglumine in healthy adult subjects demonstrated a mean elimination half-life (reported as mean ± SD) of about 1.4 ± 0.2 hr and 2.0 ± 0.7 hr in female and male subjects, respectively. Similar pharmacokinetic profile and elimination half-life values were observed after intravenous injection of 0.1 mmol/kg of gadoterate meglumine followed 20 minutes later by a second injection of 0.2 mmol/kg (1.7 ± 0.3 hr and 1.9 ± 0.2 hr in female and male subjects, respectively).

Distribution The volume of distribution at steady state of total gadolinium in healthy subjects is 179 ± 26 and 211 ± 35 mL/kg in female and male subjects respectively, roughly equivalent to that of extracellular water. Gadoterate does not undergo protein binding in vitro . The extent of blood cell partitioning of gadoterate is not known.

Following GBCA administration, gadolinium is present for months or years in brain, bone, skin and other organs [see Warnings and Precautions ( 5.4 )]. Metabolism Gadoterate is not known to be metabolized. Elimination Following a 0.1 mmol/kg dose of gadoterate meglumine, total gadolinium is excreted primarily in the urine with 72.9 ± 17.0 % and 85.4 ± 9.7 % (mean ± SD) eliminated within 48 hours, in female and male subjects, respectively.

Similar values were achieved after a cumulative dose of 0.3 mmol/kg (0.1 + 0.2 mmol/kg, 20 minutes later), with 85.5 ± 13.2 % and 92.0 ± 12.0 % recovered in urine within 48 hrs in female and male subjects respectively. In healthy subjects, the renal and total clearance rates of total gadolinium are comparable (1.27 ± 0.32 and 1.74 ± 0.12 mL/min/kg in females; and 1.40 ± 0.31 and 1.64 ± 0.35 mL/min/kg in males, respectively) indicating that the drug is primarily cleared through the kidneys. Within the studied dose range (0.1 to 0.3 mmol/kg), the kinetics of total gadolinium appear to be linear.

Specific Populations Renal Impairment A single intravenous dose of 0.1 mmol/kg of gadoterate meglumine was administered to 8 patients (5 men and 3 women) with impaired renal function (mean serum creatinine of 498 ± 98 µmol/L in the 10 to 30 mL/min creatinine clearance group and 192 ± 62 µmol/L in the 30 to 60 mL/min creatinine clearance group). Renal impairment delayed the elimination of total gadolinium. Total clearance decreased as a function of the degree of renal impairment.

The distribution volume was unaffected by the severity of renal impairment (Table 5). No changes in renal function test parameters were observed after gadoterate meglumine injection… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 123 words ▾

12.1Mechanism of Action Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: 1. differences in proton density 2. differences of the spin-lattice or longitudinal relaxation times (T1) 3. differences in the spin-spin or transverse relaxation time (T2) When placed in a magnetic field, gadoterate shortens the T1 and T2 relaxation times in target tissues.

At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Gadoterate Meglumine Injection, USP is a clear, colorless to yellow solution containing 0.5 mmol per mL of gadoterate meglumine. It is supplied in single dose vials. • Gadoterate Meglumine Injection, USP is supplied in 10 mL vials containing 5 mL or 10 mL of solution, in 20 mL vials containing 15 mL or 20 mL of solution. Each single dose vial is closed with a rubber stopper and sealed with an aluminum cap and the contents are sterile.

Gadoterate Meglumine Injection, USP single-dose vials are individually packaged in a box of 10, in the following configurations: Product Code Unit of Sale Each 800105 NDC 65219-080-05 Unit of 10 NDC 65219-080-01 5 mL in glass vial 800110 NDC 65219-082-10 Unit of 10 NDC 65219-082-01 10 mL in glass vial 800115 NDC 65219-084-15 Unit of 10 NDC 65219-084-01 15 mL in glass vial 800120 NDC 65219-086-20 Unit of 10 NDC 65219-086-01 20 mL in glass vial Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Should solidification occur in the vial because of exposure to the cold, bring Gadoterate Meglumine Injection, USP to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, Gadoterate Meglumine Injection, USP should return to a clear, colorless to yellow solution. Before use, examine the product to assure that all solids are dissolved and that the container and closure have not been damaged.

Discard the vial if solids persist.

📋 Description 190 words ▾

11 DESCRIPTION Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23 H 42 O 13 N 5 Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows: CAS Registry No.

92943-93-6 Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection.

Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below: Table 4: Physicochemical Properties Parameter Value Density @ 20°C 1.1753 g/cm 3 Viscosity @ 20°C 3.4 mPa•s Viscosity @ 37°C 2.4 mPa•s Osmolality 1,350 mOsm/kg water The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively. gadot-struc-01.jpg

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION • Advise the patient to read the FDA-approved patient labeling ( Medication Guide )

17.1Nephrogenic Systemic Fibrosis Instruct patients to inform their healthcare provider if they: 1. have a history of kidney disease, or 2. have recently received a GBCA. GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. To counsel patients at risk for NSF: • Describe the clinical manifestations of NSF. • Describe procedures to screen for the detection of renal impairment.

Instruct the patients to contact their physician if they develop signs or symptoms of NSF following Gadoterate Meglumine Injection administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.

17.2Common Adverse Reactions Inform patients that they may experience: • Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site. • Side effects of headache, nausea, abnormal taste and feeling hot.

17.3General Precautions • Pregnancy: Advise pregnant women of the potential risk of fetal exposure to gadoterate [see Use in Specific Populations ( 8.1 )] • Gadolinium Retention: Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs [see Warnings and Precautions ( 5.4 )].

Rx Only Manufactured for: Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451740E 24UF06 Made in China gadot-img-01.jpg

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Gadoterate Meglumine (GAD oh TER ate MEG loo meen) Injection (gadoterate meglumine) Injection for intravenous use What is the most important information I should know about Gadoterate Meglumine Injection? • GBCAs like Gadoterate Meglumine Injection may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if Gadoterate Meglumine Injection is safe and effective with intrathecal use. Gadoterate Meglumine Injection is not approved for this use. • Gadoterate Meglumine Injection contains a metal called gadolinium.

Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). • It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. • Rarely patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. • There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines.

Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist or MultiHance. Gadolinium stays in the body the least after Gadoterate Meglumine Injection, Gadavist or ProHance. • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. • Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis).

Your healthcare provider should screen you to see how well your kidneys are working before you receive Gadoterate Meglumine Injection. What is Gadoterate Meglumine Injection? • Gadoterate Meglumine Injection is a prescription medicine called a gadolinium-based contrast agent (GBCA). Gadoterate Meglumine Injection, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner. • An MRI exam with a GBCA, including Gadoterate Meglumine Injection, helps your doctor to see problems better than an MRI exam without a GBCA. • Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam.

Do not receive Gadoterate Meglumine Injection if you have had a severe allergic reaction to Gadoterate Meglumine Injection. Before receiving Gadoterate Meglumine Injection, tell your healthcare provider about all your medical conditions, including if you: • have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures. • are pregnant or plan to become pregnant.

It is not known if Gadoterate Meglumine Injection can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Gadoterate Meglumine Injection is received during pregnancy. • have kidney problems, diabetes, or high blood pressure. • have had an allergic reaction to dyes (contrast agents) including GBCAs. What are possible side effects of Gadoterate Meglumine Injection? • See "What is the most important information I should know about Gadoterate Meglumine Injection?" • Allergic reactions.

Gadoterate Meglumine Injection can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of Gadoterate Meglumine Injection include: nausea, headache, pain, or cold feeling at the injection site, and rash.

These are not all the possible side effects of Gadoterate Meglumine Injection. Call your doctor for medical advice about side effects. You may report… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of total gadolinium assessed up to 48 hours following an intravenously administered 0.1 mmol/kg dose of gadoterate meglumine in healthy adult subjects demonstrated a mean elimination half-life (reported as mean ± SD) of about 1.4 ± 0.2 hr and 2.0 ± 0.7 hr in female and male subjects, respectively. Similar pharmacokinetic profile and elimination half-life values were observed after intravenous injection of 0.1 mmol/kg of gadoterate meglumine followed 20 minutes later by a second injection of 0.2 mmol/kg (1.7 ± 0.3 hr and 1.9 ± 0.2 hr in female and male subjects, respectively).

Distribution The volume of distribution at steady state of total gadolinium in healthy subjects is 179 ± 26 and 211 ± 35 mL/kg in female and male subjects respectively, roughly equivalent to that of extracellular water. Gadoterate does not undergo protein binding in vitro . The extent of blood cell partitioning of gadoterate is not known.

Following GBCA administration, gadolinium is present for months or years in brain, bone, skin and other organs [see Warnings and Precautions ( 5.4 )]. Metabolism Gadoterate is not known to be metabolized. Elimination Following a 0.1 mmol/kg dose of gadoterate meglumine, total gadolinium is excreted primarily in the urine with 72.9 ± 17.0 % and 85.4 ± 9.7 % (mean ± SD) eliminated within 48 hours, in female and male subjects, respectively.

Similar values were achieved after a cumulative dose of 0.3 mmol/kg (0.1 + 0.2 mmol/kg, 20 minutes later), with 85.5 ± 13.2 % and 92.0 ± 12.0 % recovered in urine within 48 hrs in female and male subjects respectively. In healthy subjects, the renal and total clearance rates of total gadolinium are comparable (1.27 ± 0.32 and 1.74 ± 0.12 mL/min/kg in females; and 1.40 ± 0.31 and 1.64 ± 0.35 mL/min/kg in males, respectively) indicating that the drug is primarily cleared through the kidneys. Within the studied dose range (0.1 to 0.3 mmol/kg), the kinetics of total gadolinium appear to be linear.

Specific Populations Renal Impairment A single intravenous dose of 0.1 mmol/kg of gadoterate meglumine was administered to 8 patients (5 men and 3 women) with impaired renal function (mean serum creatinine of 498 ± 98 µmol/L in the 10 to 30 mL/min creatinine clearance group and 192 ± 62 µmol/L in the 30 to 60 mL/min creatinine clearance group). Renal impairment delayed the elimination of total gadolinium. Total clearance decreased as a function of the degree of renal impairment.

The distribution volume was unaffected by the severity of renal impairment (Table 5). No changes in renal function test parameters were observed after gadoterate meglumine injection. The mean cumulative urinary excretion of total gadolinium was approximately 76.9 ± 4.5% in 48 hrs in patients with moderate renal impairment, 68.4 ± 3.5% in 72 hrs in patients with severe renal impairment and 93.3 ± 4.7% in 24 hrs for subjects with normal renal function.

Table 5: Pharmacokinetic Profile of Total Gadolinium in Normal and Renally Impaired Patients Population Elimination Half-life (hr) Plasma Clearance (L/h/kg) Distribution Volume (L/kg) Healthy volunteers 1.6 ± 0.2 0.10 ± 0.01 0.246 ±

0.03Patients with moderate renal impairment 5.1 ± 1.0 0.036 ± 0.007 0.236 ±

0.01Patients with severe renal impairment 13.9 ± 1.2 0.012 ± 0.001 0.234 ±

0.01Gadoterate was shown to be dialyzable after an IV injection of gadoterate meglumine in 10 patients with end-stage renal failure who required hemodialysis treatment. Gd serum concentration decreased over time by 88%, 93% and 97% at 0.5 hr, 1.5 hr, and 4 hrs after start of dialysis, respectively. A second and third hemodialysis session further removed Gd.

After the third dialysis, Gd serum concentration decreased by 99.7%. Pediatric population The pharmacokinetics of gadoterate in pediatric patients receiving gadoterate meglumine aged birth (term neonates) to 23 months, was investigated in an open label, multicenter study, using a population pharmacokine… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 67 words ▾

12.2Pharmacodynamics Gadoterate affects proton relaxation times and consequently the MR signal, and the contrast obtained is characterized by the relaxivity of the gadoterate molecule. The relaxivity values for gadoterate are similar across the spectrum of magnetic field strengths used in clinical MRI (0.2 to

1.5T). Disruption of the blood-brain barrier or abnormal vascularity allows distribution of gadoterate in lesions such as neoplasms, abscesses, and infarcts.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES CNS Imaging Efficacy and safety of gadoterate meglumine were evaluated in a multi-center clinical trial (Study A) that enrolled 364 adult and 38 pediatric patients (aged ≥ 2 years) with known or suspected CNS lesions. Adults were randomized 2 to 1 to receive either gadoterate meglumine or gadopentetate dimeglumine, each administered at a dose of 0.1 mmol/kg. All pediatric patients received gadoterate meglumine, also at a dose of 0.1 mmol/kg.

In the trial, patients first underwent a baseline (pre-contrast) MRI examination followed by the assigned GBCA administration and a post-contrast MR examination. The images (pre-contrast, post-contrast and “paired pre- and post-contrast”) were interpreted by three independent off-site readers blinded to clinical information. The primary efficacy analysis compared three patient-level visualization scores (paired images) to baseline MRI (pre-contrast images) for adults who received gadoterate meglumine.

The three primary visualization components were: contrast enhancement, border delineation and internal morphology. For each of these components there was a pre-defined scoring scale. Lesion counting (up to five per patient) was also reflected within each component’s patient-level visualization score.

Among the adult patients, 245 received gadoterate meglumine and their data comprised the primary efficacy population. There were 114 (47%) men and 131 (53%) women with a mean age of 53 years (range 18 to 85 years), the racial and ethnic representations were 84% Caucasian, 11% Asian, 4% Black, and 1% other. Table 6 displays a comparison of paired images (pre- and post-contrast) to pre-contrast images with respect to the proportion of patients who had paired image scores that were greater “better”, or same/worse “not better” than the pre-contrast scores and with respect to the difference in the mean patient level visualization score.

Across the three readers 56% to 94% of patients had improved lesion visualization for paired images compared to pre-contrast images. Gadoterate meglumine provided a statistically significant improvement for all three primary visualization components. More lesions were seen on the paired images than the pre-contrast images.

Table 6: Study A. Improvement in Patient-level Lesion Visualization Scores, Paired versus Pre-contrast Images (a) (a) Better: number of patients with paired (pre- and post-contrast) score greater than the pre-contrast score Not better: number of patients with paired score same as or worse than the pre-contrast score Missing: number of patients with missing score (b) Difference = paired mean score minus pre-contrast mean score *Statistically significant improvement by paired t-test Lesion Scores Reader 1 Reader 2 Reader 3 n = 231 n = 232 n = 237 Border Delineation Better 195 (84%) 215 (93%) 132 (56%) Not Better 28 (12%) 7 (3%) 88 (37%) Missing 8 (4%) 10 (4%) 17 (7%) Difference in Mean Score (b) 2.26 * 2.89 * 1.17 * Internal Morphology Better 218 (94%) 214 (93%) 187 (79%) Not Better 5 (2%) 8 (3%) 33 (14%) Missing 8 (4%) 10 (4%) 17 (7%) Difference in Mean Score (b) 2.74 * 2.75 * 1.54 * Contrast Enhancement Better 208 (90%) 216 (93%) 208 (88%) Not Better 15 (6%) 6 (3%) 12 (5%) Missing 8 (4%) 10 (4%) 17 (7%) Difference in Mean Score (b) 3.09 * 3.69 * 2.92 * In secondary analyses, post-contrast images were improved in comparison to pre-contrast images.

Gadoterate meglumine lesion visualization scores were similar to those for gadopentetate dimeglumine. Gadoterate meglumine imaging results in the pediatric patients were also similar to those seen in adults. In a second clinical trial (Study B), MR images were reread from 150 adult patients with known CNS lesions who had participated in previously conducted clinical trial.

Gadoterate meglumine administration and image interpretation was performed in the same manner as in Study A. Similar to Study A, this trial also demonstrated improved lesion visualization with gadoterate meglumine. CNS… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of gadoterate meglumine. Gadoterate meglumine did not demonstrate mutagenic potential in in vitro bacterial reverse mutation assays (Ames test) using Salmonella typhimurium, in an in vitro chromosome aberration assay in Chinese hamster ovary cells, in an in vitro gene mutation assay in Chinese hamster lung cells, nor in an in vivo mouse micronucleus assay. No impairment of male or female fertility and reproductive performance was observed in rats after intravenous administration of gadoterate meglumine at the maximum tested dose of 10 mmol/kg/day (16 times the maximum human dose based on surface area), given during more than 9 weeks in males and more than 4 weeks in females.

Sperm counts and sperm motility were not adversely affected by treatment with the drug.

13.2Animal Toxicology and/or Pharmacology Local intolerance reactions, including moderate irritation associated with infiltration of inflammatory cells were observed after perivenous injection in rabbits suggesting the possibility of local irritation if the contrast medium leaks around the veins in a clinical setting [see Warnings and Precautions ( 5.5 )] . Toxicity of gadoterate meglumine was evaluated in neonatal and juvenile (pre- and post-weaning) rats following a single or repeated intravenous administration at doses 1, 2, and 4 times the MHD based on BSA.

Gadoterate meglumine was well tolerated at all dose levels tested and had no effect on growth, pre-weaning development, behavior and sexual maturation.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 139 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of gadoterate meglumine. Gadoterate meglumine did not demonstrate mutagenic potential in in vitro bacterial reverse mutation assays (Ames test) using Salmonella typhimurium, in an in vitro chromosome aberration assay in Chinese hamster ovary cells, in an in vitro gene mutation assay in Chinese hamster lung cells, nor in an in vivo mouse micronucleus assay. No impairment of male or female fertility and reproductive performance was observed in rats after intravenous administration of gadoterate meglumine at the maximum tested dose of 10 mmol/kg/day (16 times the maximum human dose based on surface area), given during more than 9 weeks in males and more than 4 weeks in females.

Sperm counts and sperm motility were not adversely affected by treatment with the drug.

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL – 2.5 mmol per 5 mL Tray Label NDC 65219- 080 -05 Gadoterate Meglumine Injection, USP 2.5 mmol per 5 mL (0.5 mmol per mL) For Intravenous Administration Sterile Solution 10 x 5 mL Single Dose Vials Discard Unused Portion Rx only gadot-label-01.jpg

PRINCIPAL DISPLAY PANEL – 2.5 mmol per 5 mL Carton NDC 65219- 080 -01 Gadoterate Meglumine Injection, USP 2.5 mmol per 5 mL (0.5 mmol per mL) For Intravenous Administration Dispense the Medication Guide provided separately to each patient. Sterile Solution 5 mL Single Dose Vial Discard Unused Portion Rx only gadot-label-02.jpg

PRINCIPAL DISPLAY PANEL – 2.5 mmol per 5 mL Vial Label NDC 65219- 080 -01 Gadoterate Meglumine Injection, USP 2.5 mmol per 5 mL (0.5 mmol per mL) For Intravenous Administration Dispense the Medication Guide provided separately to each patient. Sterile Solution 5 mL Single Dose Vial Discard Unused Portion Rx only gadot-label-03.jpg

PRINCIPAL DISPLAY PANEL – 5 mmol per 10 mL Tray Label NDC 65219- 082 -10 Gadoterate Meglumine Injection, USP 5 mmol per 10 mL (0.5 mmol per mL) For Intravenous Administration Sterile Solution 10 x 10 mL Single Dose Vials Discard Unused Portion Rx only gadot-label-04.jpg

PRINCIPAL DISPLAY PANEL – 5 mmol per 10 mL Carton NDC 65219- 082 -01 Gadoterate Meglumine Injection, USP 5 mmol per 10 mL (0.5 mmol per mL) For Intravenous Administration Dispense the Medication Guide provided separately to each patient. Sterile Solution 10 mL Single Dose Vial Discard Unused Portion Rx only gadot-label-05.jpg

PRINCIPAL DISPLAY PANEL – 5 mmol per 10 mL Vial Label NDC 65219- 082 -01 Gadoterate Meglumine Injection, USP 5 mmol per 10 mL (0.5 mmol per mL) For Intravenous Administration Dispense the Medication Guide provided separately to each patient. Sterile Solution 10 mL Single Dose Vial Discard Unused Portion Rx only gadot-label-06.jpg

PRINCIPAL DISPLAY PANEL – 7.5 mmol per 15 mL Tray Label NDC 65219- 084 -15 Gadoterate Meglumine Injection, USP 7.5 mmol per 15 mL (0.5 mmol per mL) For Intravenous Administration Sterile Solution 10 x 15 mL Single Dose Vials Discard Unused Portion Rx only gadot-label-07.jpg

PRINCIPAL DISPLAY PANEL – 7.5 mmol per 15 mL Carton NDC 65219- 084 -01 Gadoterate Meglumine Injection, USP 7.5 mmol per 15 mL (0.5 mmol per mL) For Intravenous Administration Dispense the Medication Guide provided separately to each patient. Sterile Solution 15 mL Single Dose Vial Discard Unused Portion Rx only gadot-label-08.jpg

PRINCIPAL DISPLAY PANEL – 7.5 mmol per 15 mL Vial Label NDC 65219- 084 -01 Gadoterate Meglumine Injection, USP 7.5 mmol per 15 mL (0.5 mmol per mL) For Intravenous Administration Dispense the Medication Guide provided separately to each patient. Sterile Solution 15 mL Single Dose Vial Discard Unused Portion Rx only gadot-label-09.jpg

PRINCIPAL DISPLAY PANEL – 10 mmol per 20 mL Tray Label NDC 65219- 086 -20 Gadoterate Meglumine Injection, USP 10 mmol per 20 mL (0.5 mmol per mL) For Intravenous Administration Sterile Solution 10 x 20 mL Single Dose Vials Discard Unused Portion Rx only gadot-label-10.jpg

PRINCIPAL DISPLAY PANEL – 10 mmol per 20 mL Carton NDC 65219- 086 -01 Gadoterate Meglumine Injection, USP 10 mmol per 20 mL (0.5 mmol per mL) For Intravenous Administration Dispense the Medication Guide provided separately to each patient. Sterile Solution 20 mL Single Dose Vial Discard Unused Portion Rx only gadot-label-11.jpg

PRINCIPAL DISPLAY PANEL – 10 mmol per 20 mL Vial Label NDC 65219- 086 -01 Gadoterate Meglumine Injection, USP 10 mmol per 20 mL (0.5 mmol per mL) For Intravenous Administration Dispense the Medication Guide provided separately to each patient. Sterile Solution 20 mL Single Dose Vial Discard Unused Portion Rx only gadot-label-12.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code A9575 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 65219-0066-10 · Fresenius 65219-0082-10 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.